Covid19NCT04932967
Use of nMoABs for the Treatment of COVID-19 in Patients With HM.
An observational study of Covid19 and Hematological Malignancy, run by Gruppo Italiano Malattie EMatologiche dell'Adulto at 14 sites in Italy.
Trial summary
This is a multicenter retrospective, non-interventional observational study to evaluate the efficacy of nMoAbs in HM patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid19, Hematological Malignancy
- How many people
- 91 participants
- Where
- 14 sitesItaly
- Study dates
- 30 Sep 2021to 11 Apr 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population will include patients older than 18 years of age with HM who received nMoAbs, approved by AIFA, for the treatment of SARS-CoV-2 infection.
Who may be able to join
- All patients must meet all the following criteria for study entry:
- Age equal to or greater than 18 years of age.
- Diagnosis of HM (acute leukemias, myelodysplastic syndromes, myeloproliferative neoplasms, lymphomas, myeloma, chronic myeloprolipherative disorders) at any stage/status.
- Third generation rapid molecular or antigen test positive for SARS-CoV-2 from February 2020 until May 2021
- Treatment with anti SARS CoV 2 nMoAbs approved by AIFA
- Not hospitalized for COVID-19 at the time of nMoAbs administration
Show all 21Show fewer
- Not on oxygen therapy at the time of nMoAbs administration
- At least one of the following symptoms for no more than 10 days:
- Fever
- Cough
- Anosmia
- Ageusia / dysgeusia
- Pharyngodynia
- Asthenia
- Headache
- Nausea
- Diarrhea
- Myalgia
- Dyspnea
- Tachypnea
- Signed written informed consent according to ICH/EU/GCP and national local laws (if applicable).
Who cannot join
- 1. Hematological diseases, other than HM.
- 2. Not tested positive for SARS-CoV-2
- 3. Patients in disease remission "off therapy" for more than 6 months
- 4. Immune plasma treatment in the previous two months
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
Italy14 sites
Aou Consorziale Policlinico - Uo Ematologia Con Trapianto
Bari
Asst Degli Spedali Civili Di Brescia
Brescia
Ospedale Valduce - Uos Ematologia
Como
Aou Careggi
Florence
Irccs Aou San Martino
Genova
Fondazione Irccs "Istituto Nazionale Tumori"
Milan
Aou Maggiore Della Carità Di Novara
Novara
AOU Padova
Padova
Aou Pisana - Uo Ematologia Universitaria
Pisa
Fondazione Policlinico Universitario Agostino Gemelli-Irccs
Roma
Aou "San Giovanni Di Dio E Ruggi D'Aragona" - Salerno - Uoc Ematologia E Trapianti Di Cellule Staminali Emopoietiche
Salerno
Aou Senese
Siena
Asui Di Udine, Presidio Ou "S. Maria Della Misericordia"
Udine
Asst Dei Sette Laghi, Ospedale Di Circolo E Fondazione Macchi
Varese
About this study
Official title: Use of Neutralizing Monoclonal Antibodies for the Treatment of COVID-19 in Patients With Hematological Malignancies (SIE-GIMEMA Study)
This is a multicenter retrospective, non-interventional observational study to evaluate the efficacy of nMoAbs in HM patients.
Read the detailed description
This is a multicenter retrospective, non-interventional observational study. The participating centres will retrospectively review all episodes of SARS-CoV-2 infection occurring in HMs identified at their institutions from February 2020 to May 2021 and treated with nMoAbs, to evaluate their efficacy.
- Conditions
- Covid19, Hematological Malignancy
- Keywords
- Neutralizing Monoclonal Antibodies
- Medical subject headings
- COVID-19, Hematologic Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
time to SARS-nCov-2 test negativization
To assess the efficacy of nMoAbs in infected HM patients compared to the historical control
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2021
- Study start30 Sep 2021
- Primary completion11 Apr 2022
- Study completion11 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Covid19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gruppo Italiano Malattie EMatologiche dell'Adulto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04932967
- Sponsor's protocol ID
- EMATO0321
- Status last verified
- Jun 2022
- First submitted
- 17 Jun 2021
- Last updated
- 22 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Marasco V, Piciocchi A, Candoni A, Pagano L, Guidetti A, Musto P, Bruna R, Bocchia M, Visentin A, Turrini M, Tucci A, Pilerci S, Fianchi L, Salvini M, Galimberti S, Coviello E, Selleri C, Luppi M, Crea E, Fazi P, Passamonti F, Corradini P. Neutralizing monoclonal antibodies in haematological patients paucisymptomatic for COVID-19: The GIMEMA EMATO-0321 study. Br J Haematol. 2022 Oct;199(1):54-60. doi: 10.1111/bjh.18385. Epub 2022 Jul 30.
PubMed 35906881
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Neutralizing Monoclonal Antibodies for the Treatment of COVID-19 in Patients With Hematological Malignancies (SIE-GIMEMA Study)
- ClinicalTrials.gov ID
- NCT04932967
- Acronym / sponsor ID
- EMATO0321
- Conditions
- Covid19, Hematological Malignancy
- Keywords
- Neutralizing Monoclonal Antibodies
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- Gruppo Italiano Malattie EMatologiche dell'AdultoUniversity, hospital or other
- Study start
- 30 Sep 2021 (actual)
- Primary completion
- 11 Apr 2022 (actual)
- Study completion
- 11 Apr 2022 (actual)
- First posted
- 21 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a multicenter retrospective, non-interventional observational study to evaluate the efficacy of nMoAbs in HM patients.
Detailed description
This is a multicenter retrospective, non-interventional observational study. The participating centres will retrospectively review all episodes of SARS-CoV-2 infection occurring in HMs identified at their institutions from February 2020 to May 2021 and treated with nMoAbs, to evaluate their efficacy.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will include patients older than 18 years of age with HM who received nMoAbs, approved by AIFA, for the treatment of SARS-CoV-2 infection.
Key inclusion criteria (21 listed)
- All patients must meet all the following criteria for study entry:
Key exclusion criteria (4 listed)
- 1. Hematological diseases, other than HM.
- 2. Not tested positive for SARS-CoV-2
- 3. Patients in disease remission "off therapy" for more than 6 months
- 4. Immune plasma treatment in the previous two months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
time to SARS-nCov-2 test negativization
Time frame: 3 months
To assess the efficacy of nMoAbs in infected HM patients compared to the historical control
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2022.
- Derived from this study: PubMed 35906881Marasco V, Piciocchi A, Candoni A, Pagano L, Guidetti A, Musto P, Bruna R, Bocchia M, Visentin A, Turrini M, Tucci A, Pilerci S, Fianchi L, Salvini M, Galimberti S, Coviello E, Selleri C, Luppi M, Crea E, Fazi P, Passamonti F, Corradini P. Neutralizing monoclonal antibodies in haematological patients paucisymptomatic for COVID-19: The GIMEMA EMATO-0321 study. Br J Haematol. 2022 Oct;199(1):54-60. doi: 10.1111/bjh.18385. Epub 2022 Jul 30.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Covid19 and Hematological Malignancy, run by Gruppo Italiano Malattie EMatologiche dell'Adulto at 14 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 21 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
time to SARS-nCov-2 test negativization (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04932967, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2022.